UDI realizes the full life cycle management of medical devices, can effectively supervise medical devices, monitor adverse events, quickly recall problem products in the event of adverse events, and effectively trace the source of accidents.
What is UDI
UDI (Unique Device Identification) is the abbreviation of the unique identification of medical devices, which is attached to the medical device product or packaging, consisting of numbers, letters or symbols**, which is used to uniquely identify medical devices. Realize the recording of medical device identification and various product data, and confirm the attribute information such as the manufacturer, model, and specification of the product, so as to facilitate supervision and traceability.
Composition of UDI
UDI = Product Identification (DI) + Production Identification (PI).
1.Product Identification (DI):DI is a unique identifier for the device. This identifier is generated by the manufacturer according to the coding rules specified in the standard to ensure uniqueness worldwide. DI uses an encoding format called GS1, which is one of the world's common commodity barcode standards, so DI can be compared with the barcode of other products, so that products from different manufacturers can also correspond to each other.
2.Production Identifier (PI):PI is a unique identifier for the equipment manufacturer, which is assigned by a unique organization in the world**. The function of this ** is to identify the relevant information of the medical device production process, such as the production batch number, production date, expiration date, serial number, etc.
UDI implementation process
According to the Rules for the Unique Identification System for Medical Devices, the process for the registrant to implement the unique identification is as follows:
1.Select the code issuing agency:Registrant The filing person shall select the code issuing agency in accordance with the "Rules" and relevant standards, combined with the actual situation of the enterprise. The UDI public platform is compatible with GS1 and MA coding systems, which can be selected according to the needs of enterprises.
2.Production products di:Registrant The filing person creates the product identification in accordance with the standards of the code issuing agency and determines the composition of the production identification of the product. The UDI public platform platform can generate DI and PI in batches according to the coding rules, and the algorithm is automatically generated without coding detection.
3.Registration and filing declaration:From the date of implementation of the Rules, if a medical device is registered, registered or filed for the record, the registrant and the record-filing person shall submit the product identification in the registration and filing management system. If the enterprise product is in the registration stage, the UDI-DI information can be generated in advance with the help of the UDI public platform for submission during registration and filing.
4.Label printing and coding:Registrant The filing person selects the appropriate data carrier according to the standards of the code issuing agency, and gives the medical device a unique identification data carrier on the minimum sales unit of the medical device and the higher-level packaging or medical device product.
The label design is carried out through the DI and PI data generated by the platform, and the platform teacher guides the enterprise to print the label and code for compliance according to the actual situation.
5.Upload the database:Registrant The filing person uploads the product identification and related information to the medical device unique identification database before the product is put on sale. The UDI public platform is directly connected to the database of the Food and Drug Administration, and enterprises only need to click on the one-click declaration to realize DI data upload.
6.Registration Filing Change:When the product identification and data-related information changes, the registrant and the filing person shall update the unique identification database of medical devices in a timely manner. Enterprises can quickly update or change product data through the UDI public platform.
The establishment of the UDI system will help improve the accuracy of all aspects of medical devices from production, sales to terminal use, improve the level of enterprise information management, improve the overall service level, and ensure patient safety. Realize that the medical devices can be traced, the whereabouts can be traced, and the responsibility can be investigated.